INTEGRATED SOLUTIONS

PARTNERING WITH CLIENTS TO PROVIDE GLOBAL INTEGRATED SOLUTIONS

Commissioning, Qualification, Validation (CQV)

www.jacobs.comOffices Worldwide

COMMISSIONING , QUAL IF ICAT ION & VAL IDAT ION ( C QV )

As the largest provider of professional services in the biopharmaceutical industry, clients benefit from both our local presence and global reach. Jacobs offers a range of services from advanced planning and programming to design, construction and commissioning to startup, qualification and validation. This allows us to help our clients throughout the life cycle of a project.

Our team takes advantage of a unified approach that uses dedicated CQV resources and engages automation, process and construction engineers to provide clients with comprehensive end-to-end project solutions.

By implementing an integrated project delivery strategy, based on collaboration between design, construction and CQV, we are able to deliver best-in-class facilities as efficiently as possible. We identify and resolve issues early to avoid expensive rework and use standard processes to improve our effectiveness.

The result - we design, build, commission, qualify, and validate facilities right the first time bringing clients’ products to market more quickly; this results in patients receiving the medicines they need and a faster return on your investment.

PROJECT EXAMPLES

Integrated Solutions

Multiple Projects Services: CQV

We partnered with a major pharmaceutical client across the globe to provide CQV services. Projects include:

� Cleaning validation, Malaysia � Critical component assessment, United Kingdom

� cGMP & impact assessment, China

� cGMP Review and GAP Analysis, South Africa

� Facility risk assessment, Philippines

� Full lifecycle C&Q services, Ireland & UK

APS Pressurization and cGMP Upgrades Services: CQV

We provided full verification services including project management, protocol development & execution, and change management support for an aseptic facility upgrade project. Project scope included modifications to the facility, depyrogenation tunnel, and clean utilities, as well as new Grade B & D air handling units. All work was required to be completed during an eight-week shutdown.

mAb Fill/Pack Services: EP+CQV

We are providing all CQV services for a greenfield biologics manufacturing facility in Northern Europe designed to provide production capability for a range of large-molecule, protein therapeutic products. Project scope includes URs, DQ, FAT, SAT, Startup, Commissioning, IQ, and OQ for syringe & vial filling, formulation, inspection, labeling, and packaging processes.

Vaccine Bulk Facility Services: EPCM+CQV

We provided EPCM+CQV services, achieving an unprecedented 24-month schedule from charter to operational qualification for this $315 million, 214,000-square-foot, vaccine manufacturing facility. One third of craft hours were moved off site which allowed modular construction to take place while the facility layout was still being developed (interstitial, AHU, duct risers, clean room panels). Using this hybrid approach, we completed the project 40 percent faster than industry benchmarks.

AREAS OF SPEC IALTY

Our experience, expertise, and commitment provides superior services to meet your validation and compliance needs.

WHY JACOBS?

� We employ self-motivated, high-caliber CQV resources.

� We are the largest provider of integrated engineering, procurement, construction management and validation services and understand the importance of front-end loading CQV activities.

� We use design, automation and construction resources to support and optimize commissioning and qualification.

� We are an established Life Sciences market leader that has experience with emerging technologies such as gene therapy, cell therapy, nanotechnology and single use manufacturing.

� We leverage our large network of available SMEs to deliver value to our clients.

� We get client’s products to market faster with right-sized, scalable project delivery strategies.

� We partner with clients to focus on people, performance, safety and integrity - our core values and the foundation of our Company.

� We minimize costs by using local resources in strategic locations around the world.

� We can accommodate any science and risk-based life cycle approach whether it is ASTM E2500, BG5 or GAMP 5.

� We use standard processes and data management tools to provide compliant and predictable turnkey solutions that streamline project delivery.

CORE CQV SERVICES SUPPORT SERVICES CONSULTING SERVICES

� CQV Master Planning

� Requirements Development

� Risk Assessments

� Design Review and Qualification

� Factory & Site Acceptance Testing

� Startup & Commissioning

� Qualification

� Cleaning & Sterilization Validation

� Process Validation

� SOP Development

� Personnel Training

� Maintenance & Reliability

� CAPA & Change Management

� Environmental Monitoring

� Temperature Mapping

� Calibrations and Loop Checks

� Serialization

� Computer System Validation

� Site Master Planning

� Project Management

� Compliance Gap Analysis

� Quality System Auditing

� Mock Inspections

� Design Consultation

� Product Life Cycle Management

� Aseptic Processing

� Tech Transfer

Proven Leadership

Our team brings in-depth knowledge and expertise in CQV and related services. With proficient leaders around the globe, we understand international and local regulations and are able to use our knowledge and experience to deliver:

� Cost-effective, compliant solutions

� Products to market faster

� Reliable facilities that support sustainable operations and

process improvements

Mr. Scott Hamm has nearly 30 years of engineering and management experience in a regulated environment. He has a strong C&Q background and experience developing quality system documentation (e.g., standards, policies, procedures) and processes for pharmaceutical, biotech and medical device manufacturers.

Mr. Hamm has served as a member of the ISPE Steering Committee for the Commissioning and Qualification Community of Practice. He was a reviewer of the ASTM E2500 Standard, as well as the ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment. He was an author of the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011.

Dr. Archa Vermani has more than 15 years of diversified experience in the field of designing and complying facility as per cGMP requirements which also includes planning and executing CQV activities. She is responsible for CQV and Regulatory compliance for India projects and plays a key role in project setup.

Dr. Vermani has successfully delivered many National and International CQV projects with different formulations like Sterile, OSD, API, Biotech/Vaccines, Blood Plasma Fractionation and FMCG.

Mr. David Tyrrell has more than 25 years in engineering and project management across diverse industries and has a proven track record in building teams and delivering projects. He is responsible for CQV and Regulatory compliance for Ireland, UK & European support.

Mr. Tyrrell has a broad range of CQV experience and has Managed CQV teams through project life cycle from concept, building process systems, resourcing, team building, start-up, Commissioning, Qualification, Validation through to sustaining.

With over 20 years Client side experience, Mr. Tyrrell has a clear understanding of customer needs and strives to partner with Clients as a solution provider.

FOR FURTHER INFORMATION CONTACT:

DAVID TYRRELLPhone: +353 (0)1 2027787 David.Tyrrell@jacobs.com

DR. ARCHA VERMANIPhone: +91 124 3372527

Archa.Vermani@jacobs.com

SCOTT HAMMPhone: +1.317.850.8797

Scott.Hamm@jacobs.com

SCOTT HAMMUS Director of CQV

and Compliance Services

DAVID TYRRELLIreland, UK and Scandinavia Director of CQV

and Compliance Services

DR. ARCHA VERMANIIndia Manager of CQV

and Compliance Services